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Completed

NCT Number: NCT05514509

A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be ≥18 years of age, at the time of signing the informed consent.
  • HIV negative at screening. Type of HIV-1 test is per standard of care.
  • No prior history of receiving oral CAB or CAB LA injections.
  • PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
  • Female at birth or self-identified Transgender Female.
  • Self-identified as African American/Black
  • Capable of giving signed informed consent

Exclusion criteria

  • HIV indeterminate or positive test result during screening.
  • A participant of concurrent interventional clinical or implementation science study at any time during the study.
  • Cis-gender or Transgender male

Treatment and study plan

APRETUDE

Drug

Available as intramuscular injection.

Cabotegravir tablet

Drug

Available as marketed orally administered tablets.

Primary outcomes

  1. Mean Intervention Appropriateness Measure (IAM) Score in SSPs

    Time frame: Up to Month 13

    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Secondary outcomes

  1. Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13

    Time frame: Month 1, 4, 5, 12 and 13

    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  2. Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13

    Time frame: Baseline (Month 1) and Month 4, 5, 12 and 13

    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  3. Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  4. Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13

    Time frame: Month 1, 4, 5, 12 and 13

    Appropriateness of APRETUDE will be measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interview. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  5. Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13

    Time frame: Month 4, 5 12 and 13

    Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in.

  6. Mean IAM Score in PSPs at Month 1, 4, 5, 12 and 13

    Time frame: Month 1, 4, 5, 12 and 13

    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  7. Change from Baseline in Mean IAM Score in PSPs at Month 4, 5, 12 and 13

    Time frame: Baseline (Month 1) and Month 4, 5, 12 and 13

    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  8. Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at Month 1, 4, 5, 12 and 13

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  9. Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at Month 4, 5, 12 and 13

    Time frame: Month 4, 5, 12 and 13

    Perception of Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in.

  10. Number of cis-and trans Black women who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on site-level PrEP Information Questionnaire

    Time frame: Up to Month 13

  11. Number of PSPs who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on Site-level PrEP Information Questionnaire

    Time frame: Up to Month 13

  12. Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire

    Time frame: Up to Month 13

  13. Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire

    Time frame: Up to Month 13

  14. Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire

    Time frame: Up to Month 13

  15. Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire

    Time frame: Up to Month 13

  16. Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by study arm based on Site-level PrEP Information Questionnaire

    Time frame: Up to Month 13

  17. Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by Clinic Characteristics based on Site-level PrEP Information Questionnaire

    Time frame: Up to Month 13

  18. Mean Feasibility of Intervention Measure (FIM) score in SSPs for Implementation Strategies

    Time frame: Month 1 and 4, 5, 12 and 13

    The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  19. Change from Baseline in FIM Score in SSPs for Implementation Strategies

    Time frame: Baseline (Month 1) and Month 4, 5, 12 and 13

    The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  20. Feasibility of Strategy Assessed by SSPs Questionnaire responses at Month 1, 4, 5, 12 and 13

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  21. Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13

    Time frame: Month 4, 5, 12 and 13

    Perception of Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in.

  22. Proportion of SSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm

    Time frame: Up to Month 13

    ISQ measures a range, including acceptability, feasibility, and utility.

  23. Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics

    Time frame: Up to Month 13

    ISQ measures a range, including acceptability, feasibility, and utility.

  24. Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups

    Time frame: Up to Month 13

    ISQ measures a range, including acceptability, feasibility, and utility.

  25. Proportion of PSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm

    Time frame: Up to Month 13

    ISQ measures a range, including acceptability, feasibility, and utility.

  26. Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics

    Time frame: Up to Month 13

    ISQ measures a range, including acceptability, feasibility, and utility.

  27. Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups

    Time frame: Up to Month 13

    ISQ measures a range, including acceptability, feasibility, and utility.

  28. Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups

    Time frame: Up to Month 13

    Perceptions of Utility of Implementation tools and strategies will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.

  29. Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)

    Time frame: Up to Month 13

  30. Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by SSIs in PSPs

    Time frame: Month 1, 12 and 13

    Perception of Barriers and Facilitators to Fidelity to Injections Window will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 who start with oral lead in.

  31. Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  32. Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs

    Time frame: Month 4, 5, 12 and 13

    Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in.

  33. Proportion of PSPs completing target number of injections

    Time frame: Up to Month 13

  34. Barriers, Facilitators, Concerns and Perception to Implementation in SSPs and PSPs Assessed by Questionnaire responses

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  35. Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI

    Time frame: Month 4, 5, 12 and 13

    Perception to Facilitators and Barriers to Implementation will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in.

  36. Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC

    Time frame: Month 4, 5, 12 and 13

    Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in.

  37. Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI

    Time frame: Month 1, 12 and 13

    Perception to Facilitators and Barriers to Implementation will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 for participants who start with the oral lead in.

  38. Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs

    Time frame: Month 1, 4, 5, 12 and 13

    The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  39. FIM Score for APRETUDE in SSPs and PSPs

    Time frame: Month 1, 4, 5, 12 and 13

    The responses for feasibility will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  40. Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  41. Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs

    Time frame: Month 4, 12 and 13

    Feasibility and Acceptability of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 13 for participants who start with the oral lead in.

  42. Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs

    Time frame: Month 1, 12 and 13

    Feasibility and Acceptability of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 for participants who start with the oral lead in.

  43. Proportion of PSPs that have one Oral lead-in before CAB Injection

    Time frame: Up to Month 13

  44. Perception on Reason for Decision to Use Oral lead-in in SSPs Assessed by SSI

    Time frame: Month 1, 4, 5, 12 and 13

    Perception on Reason for Decision to Use Oral lead-in will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  45. Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses

    Time frame: Month 1, 4, 5, 12 and 13

    Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.

  46. Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs

    Time frame: Month 1

    Perception on Reason for Decision to Use Oral lead-in will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.

  47. Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses

    Time frame: Month 1

  48. Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE

    Time frame: Up to Month 13

  49. Reasons for Choosing or Switching from Oral PrEP to APRETUDE in PSPs Assessed by SSIs

    Time frame: Up to Month 13

    Reasons for Choosing or Switching from Oral PrEP to APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories

Acronym: EBONI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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